BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE 10ML FILL

    MDR report key: 9986738 · Received April 22, 2020

    Report

    Report Number
    1911916-2020-00401
    Event Type
    Malfunction
    Date Received
    April 22, 2020
    Date of Event
    April 8, 2020
    Report Date
    April 13, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLE WAS RECEIVED. NO PHOTO WAS PROVIDED; THE SAME DAY THE COMPLAINT WAS REPORTED (4/08/2020) THE MANUFACTURING SITE WAS INFORMED ABOUT IT. WE CONFIRMED THAT THESE PRODUCTS WERE RELEASED FOR SALE ON 4/01/2020 AND WERE GOOD FOR USE. THE PERSONNEL AT A DISTRIBUTION CENTER MISSED TO REMOVE THE PLACARD FROM THIS PALLET. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 42292 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: THE PERSONNEL AT A DISTRIBUTION CENTER MISSED TO REMOVE THE PLACARD FROM THIS PALLET. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 10ML REG PR SALINE 10ML FILL WAS LABELED "DEFECTIVE" AND RECEIVED BY CUSTOMER. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306546 BATCH NO.: 0042292. WE RECEIVED A PALLET TODAY THAT HAD THE BELOW SIGN ON IT: QA QUARANTINE. AWAITING TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452661 SYRINGE 10ML REG PR SALINE 10ML FILL SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306546 0042292 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other